Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT05347628 | Unknown Phase 1

• 1 other identifier: PLB1004-I-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).

Conditions

Non-Small-Cell Lung Cancer

Keywords

Non-Small-Cell Lung Cancer; EGFR; NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

  2 years

• DLTs of Orally Administered PLB1004

  Toxicity will be evaluated according to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

  28 days

• Maximum Tolerated Dose (MTD) of Orally Administered PLB1004

  The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.

  28 days

• Recommended Phase II Dose (RP2D) of Orally Administered PLB1004

  The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose.

  2 years

Secondary Outcomes (8)

• Area Under the Curve (AUC) of PLB1004

  Up to approximately 28 days; Pre-dose and multiple time points post-dose

• Maximum plasma concentration (Cmax) of PLB1004

  Up to approximately 28 days; Pre-dose and multiple time points post-dose

• Time to maximum plasma concentration (Tmax) of PLB1004

  Up to approximately 28 days; Pre-dose and multiple time points post-dose

• Overall Response Rate (ORR)

  3 years

• Progression-Free Survival (PFS)

  3 years

Study Arms (1)

PLB1004

EXPERIMENTAL

PLB1004 given alone as monotherapy.

Drug: PLB1004

Interventions

PLB1004 DRUG

PLB1004 is a capsule in the form of 10mg and 40mg.

PLB1004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document；
• Aged at least 18 years old;
• Histologically or cytologically confirmed advanced non-small cell lung cancer;
• Patients with EGFR or HER2 mutations;
• ECOG Performance Status of 0-2;
• Life expectancy is not less than 12 weeks;
• At least one measurable lesion as defined by RECIST1.1;

You may not qualify if:

• For the Dose Expansion Part: Patients who have received prior treatment with Poziotinib or TAK788 or other EGFR/HER2 exon20 insertion inhibitors should be excluded；
• Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days prior to the first dose of PLB1004；
• Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting PLB1004 or who have not recovered from side effects of such procedure;
• Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting PLB1004. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting PLB1004 is allowed;
• Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
• Strong inhibitors of CYP3A4
• Strong inducers of CYP3A4
• Inducers or inhibitors of P-gp
• Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms;
• Clinically significant, uncontrolled heart diseases;
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease;
• History of hypersensitivity to active or inactive excipients of PLB1004 or drugs with a similar chemical structure or class to PLB1004;
• Pregnant or nursing women;
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements;

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 26, 2022
• Study Start: August 25, 2020
• Primary Completion: April 4, 2023
• Study Completion: November 30, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)